(104 days)
Not Found
No
The device description focuses on the physical components and mechanism of action (laser ablation) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The performance studies are clinical trials evaluating the physical device's efficacy.
Yes
The device is used for the "endovascular treatment of symptomatic infrainguinal lower extremity vascular disease," specifically to "ablate, or debulk, the lesion material thus opening the vessel," which directly treats a medical condition.
No
Explanation: The device is described as an atherectomy catheter that uses laser energy to ablate or debulk lesions in blood vessels. Its intended use is for endovascular treatment, not for diagnosing conditions.
No
The device description clearly details a physical catheter with optical fibers and medical grade tubing, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease. This describes a therapeutic procedure performed within the patient's body.
- Device Description: The device is a laser atherectomy catheter designed to be inserted into a patient's vasculature to ablate blockages. This is a physical intervention.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such an examination of specimens.
The device is a therapeutic medical device used for a surgical procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
CLiRpath™ catheters are intended for use in ablating a channel in totally occlusive peripheral vascular disease (including the superficial femoral, popliteal and infrapopliteal arteries), for enhancing the potential for limb preservation.
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.
Product codes (comma separated list FDA assigned to the subject device)
MCW, PDU
Device Description
Spectranetics laser atherectorny catheters consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. Both over-the-wire and rapid-exchange catheter configurations are available. Laser energy impinged on a blockage ablates, or debulks, the lesion material thus opening the vessel, permitting placement of devices used in vascular interventions.
Spectranetics laser catheters are supplied in several models having tip diameters between 0.9 mm and 2.5 mm, appropriate for interventional use in peripheral arteries. Both over-the-wire and rapid exchange models are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular disease (including the superficial femoral, popliteal and infrapopliteal arteries), infrainguinal lower extremity vascular disease
Indicated Patient Age Range
Not Found
Intended User / Care Setting
attending physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human clinical studies: Forty-seven (47) patients with distal peripheral arterial disease were enrolled at investigational sites in the United States, Germany, and Belgium. The CLIRpath step by step excimer laser catheter procedure successfully crossed 79% of lesingsm step in to crossing with conventional guidewires. Overall procedural success was achieved in 72% of the cases, and straight-line blood flow was re-established to the foot in 79% of the cases. Serious adverse events associated with CLiRpath step by step treatments were more rare than those observed during a larger registry study of laser atherectomy in the arteries of the legs.
In vitro laboratory tests, as well as qualification and validation studies, have confirmed that CLiRpath catheters meet manufacturing and design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Successfully crossed lesions: 79%
Overall procedural success: 72%
Straight-line blood flow re-established to the foot: 79%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031842, K901206, K933328, K023114, K024243
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
APR 2 7 2004
510(k) SUMMARY
SUBMITTER INFORMATION
- A. Company Name: Spectranetics Corporation, Inc.
- B. Company Address: 96 Talamine Court Colorado Springs, Colorado 80907 C. Company Phone: 719-633-08333 / 1-800-633-0960
- D. Company Facsimile: 719 442 2248
- E. Contact Person: Adrian Elfe Vice President Quality Assurance & Regulatory Affairs Compliance
DEVICE IDENTIFICATION
- A. Device Trade Name: CLiRpath Excimer Laser Catheter
- B. Device Common Name: Laser Catheter
- C. Classification Name: Catheter, Peripheral, Atherectomy
- D. Device Class: Class II (per 21 CFR 870.4875)
- E. Device Code: MCW
IDENTIFICATION OF PREDICATE DEVICES
The Safe Cross Radio Frequency Total Occlusion Crossing System (IntraLuminal Therapeutics, Inc.), which received market clearance under 510(k) K031842, is the primary predicate device. Other predicate devices include: Rotablator Rotational Angioplasty Systems (Heart Technology, Inc.) cleared under 510(K) applications K901206 and K933328, the Frontrunner CTO Catheter (LuMend, Inc.) cleared inder 510(k) K023114, and the Silverhawk Peripheral Catherer System (Foxhollow) cleared under under 510(k) K024243.
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DEVICE DESCRIPTION
Spectranetics laser atherectorny catheters consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. Both over-the-wire and rapid-exchange catheter configurations are available. Laser energy impinged on a blockage ablates, or debulks, the lesion material thus opening the vessel, permitting placement of devices used in vascular interventions.
Spectranetics laser catheters are supplied in several models having tip diameters between 0.9 mm and 2.5 mm, appropriate for interventional use in peripheral arteries. Both over-the-wire and rapid exchange models are available.
INTENDED USE
CLiRpath™ catheters are intended for use in ablating a channel in totally occlusive peripheral vascular disease (including the superficial femoral, popliteal and infrapopliteal arteries), for enhancing the potential for limb preservation.
COMPARISON TO PREDICATE DEVICES
Spectranetics laser catheters for peripheral use are substantially equivalent in form, fit. and function to four (4) predicate devices, which have received market clearance inder section 510(k) rules.
Each of the devices is a catheter, i.e. a piece of tubing with a working length of approximately 100 cm, and a diameter between 0.9 mm and 6.0 mm. The catheters communicate mechanical and/or radiant energy to an occlusion within a patient's arteries in the lower limbs. Communicated energy disrupts occlusive material, such as arterial plaque, and permits its removal either when the catheter is withdrawn, soch as patient's endoreticular system. The pathway opened by each of the devices from the the subsequent placement of other devices and interventions.
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BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Biocompatibility of component materials and finished CLiRpath devices has been confirmed in accord with the ISO 10993 series of standards, Biological Evaluation of Medical Devices. Spectranetics conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Package integrity is initially validated. and, in addition, visually verified for 100% of Spectranetics devices prior to transfer to finished goods inventory.
CLiRpath device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. All excimer laser CLiRopath gathleter models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 10555-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements.
CLINICAL STUDIES
Forty-seven (47) patients with distal peripheral arterial disease were enrolled at investigational sites in the United States, Germany, and Belgium. The CLIRpath step by step excimer laser catheter procedure successfully crossed 79% of lesingsm step in to crossing with conventional guidewires. Overall procedural success was achieved in 72% of the cases, and straight-line blood flow was re-established to the foot in 79% of the cases. Serious adverse events associated with CLiRpath step by step treatments were more rare than those observed during a larger registry study of laser atherectomy in the arteries of the legs.
CONCLUSION
Human clinical studies verified the safety and performance characteristics for Spectranetics CLiRpath excimer laser catheters for use in the treatment of peripheral arterial disease. In vitro laboratory tests, as well as qualification and validation studies, have confirmed that CLiRpath catheters meet manufacturing and design specifications. All of these data combined establish substantial equivalence to the predicate devices,
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spectranetics Corpation c/o Mr. Neil Burris Senior Clinical Data Services Analyst 96 Talamine Court Colorado Springs, CO 80907
SEP 1 8 2013
Re: K040067
Trade/Device Name: CLiRpath Excimer Laser Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: March 23, 2004 Received: March 24, 2004
Dear Mr. Burris:
This letter corrects our substantially equivalent letter of April 27, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Zin.Z-
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Statement of Indication for Use
Indication for Use
510(k) Number (if known): K04000
Device Name: Spectranetics CLiRpath™ Excimer Laser Catheters
Indications for Use
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana P. Schamel
(Division Sigil-Off) Division of Cardiovascular Devices
510(k) Number_k040067
Page 1 of 1
CORRECTED PAGE 38 - CLiRpath 510k #K0400067
Spectranetics, K040067/A 1 23 March 04